JZF
5 FDA 510(k) clearances · Product code
118 daysmedian time to decision
144 days90th percentile
5clearances measured
FDA profile
- Official device name
- Tube, Ear Suction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1996: 1 · 1998: 2 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EXMOOR TYMPANOCENTESIS KIT (TK/1) (K973587) | Exmoor Plastics , Ltd. | 1998-01-23 |
| MIDDLE EAR VIEWER AND FLUID COLLECTOR (K862903) | Steven K. Juhn | 1986-11-24 |
| SHAH SELF-CLEARING MASTOID SUCTION TUBE (K853589) | Downs Surgical , Ltd. | 1985-12-23 |
| MICRO FLUID APPLICATOR (K841357) | Treace Medical, Inc. | 1984-08-24 |
| RIGID SUCTION TIPS & RELATED ITEMS (K822010) | Kelleher Corp. | 1982-08-12 |
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Every clearance here is in the API, with alerts when new ones post.